RAPID SCREENING OF HUMAN GROWTH HORMONE

描述：(从申请者的描述中扫描)： 拟议的研究是开发两个原型分析器接口 用于快速筛选人生长激素的全自动微孔板阅读器 (HGH)采用表面增强拉曼免疫分析(SIIA)。第一个原型将 被安置在临床环境中。这项研究将包括回顾和 接受生长激素评估的患者的前瞻性分析 分泌异常。我们将通过与以下内容的比较来交叉验证此工作 常规放射免疫测定。这将为我们提供一个 可信的验证和FDA批准的开始。第二个原型将 为系统优化而开发，以评估工程和测试 方法论。系统的增强将涉及因素分析 技术的可控因素。这些将包括孵化时间， 样品大小、温度、湿度、平板设计、积分时间、激光 功率、印版平移速度和化学计量参数。最佳化 将在准确度、精密度和总分析时间方面进行。 在项目过程中，任何重大的改进都将共享 第一个研究组用于他们的临床研究。这个 这两项平行研究的结果将被用来定位我们的小组 进军hGH监测市场。 建议的商业应用： 通过这项工作开发的人生长激素分析仪器将在 致力于生长激素研究的临床环境，作为高成本/低成本的替代品 目前正在使用的周转时间方法。这台仪器在研究中也很有用 必须处理大量样本的设置。

DESCRIPTION: (Scanned from the Applicant's Description): The goal of the proposed research is to develop two prototype analyzers interfaced with automated microwell plate readers for rapid screening of human growth hormone (hGH) by Surface Enhanced Raman ImmunoAssay (SERIA). The first prototype will be placed in a clinical setting. This study will include retrospective and prospective analyses of patients who have been evaluated for growth hormone secretory abnormalities. We will cross validate this work with a comparison to conventional radioimmunoassay measurements. This will provide us with a credible validation and a beginning for FDA approval. The second prototype will be developed for system optimization to evaluate the engineering and assay methodology. The system enhancement will involve a factor analysis of the controllable factors of the technique. These will include incubation time, sample size, temperature, humidity, plate design, integration time, laser power, plate translation speed, and chemometric parameters. The optimization will be performed with respect to accuracy, precision, and total assay time. During the course of the project any significant improvements will be shared with the first study group for adoption into their clinical studies. The results of these two parallel studies will be used to position our group to enter into the hGH monitoring market. PROPOSED COMMERCIAL APPLICATION: The hGH analyzer instruments developed from this work will find wide applicability in clinical settings devoted to growth hormone study as a replacement for the high cost/slow turnaround time methods currently in use. This instrument will also be useful in research settings in which large numbers of samples must be processed.